Abstract:
OBJECTIVE:To use the large dataset from the Tysabri Outreach: Unified Commitment to Health (TOUCH) program to compare progressive multifocal leukoencephalopathy (PML) risk with natalizumab extended interval dosing (EID) vs standard interval dosing (SID) in patients with multiple sclerosis (MS). METHODS:This retrospective cohort study included anti-JC virus antibody-positive patients (n = 35,521) in the TOUCH database as of June 1, 2017. The effect of EID on PML risk was evaluated with 3 planned analyses using Kaplan-Meier methods stratified by prior immunosuppressant use. Risk of PML was analyzed by Cox regression adjusted for age, sex, prior immunosuppressants, time since natalizumab initiation, and cumulative number of infusions. RESULTS:This study included 35,521 patients (primary analysis: 1,988 EID, 13,132 SID; secondary analysis: 3,331 EID, 15,424 SID; tertiary analysis: 815 EID, 23,168 SID). Mean average dosing intervals were 35.0 to 43.0 and 29.8 to 30.5 days for the EID and SID cohorts, respectively. Hazard ratios (95% confidence intervals) of PML risk for EID vs SID were 0.06 (0.01-0.22, p < 0.001) and 0.12 (0.05-0.29, p < 0.001) for the primary and secondary analyses, respectively. Relative risk reductions were 94% and 88% in favor of EID for the primary and secondary analyses, respectively. The tertiary analysis included no cases of PML with EID. CONCLUSION:Natalizumab EID is associated with clinically and statistically significantly lower PML risk than SID. CLASSIFICATION OF EVIDENCE:This study provides Class III evidence that for patients with MS, natalizumab EID is associated with a lower PML risk than SID.
journal_name
Neurologyjournal_title
Neurologyauthors
Ryerson LZ,Foley J,Chang I,Kister I,Cutter G,Metzger RR,Goldberg JD,Li X,Riddle E,Smirnakis K,Kasliwal R,Ren Z,Hotermans C,Ho PR,Campbell Ndoi
10.1212/WNL.0000000000008243subject
Has Abstractpub_date
2019-10-08 00:00:00pages
e1452-e1462issue
15eissn
0028-3878issn
1526-632Xpii
WNL.0000000000008243journal_volume
93pub_type
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